Problem Solver

Some Special Controls may apply, additionally, to some class II device types.

The first and most important step is to correctly classify your device in terms of the FDA 3-letter code. Normally this is done by identifying an equivalent device already legally in commercial distribution in the USA. Once you identify the device, look up its 3-letter code and go from there to see what Controls apply and whether the device type is exempt from premarket notification (510k), GMP (QMS), Design Controls etc.

Registered

Thanks for your reply. So in case I have already identified the product code, I have QMS in place and general and special controls documented.
The only things I need to do from the practical point of view to start to sell in US is 1) Registration and Listing 2) a petition to FDA stating the reason why we believe the device is exempted from 510k application.

Registered

a) From documentation point of view, apart being compliant to CFR 820 (QMS, design documentation etc), is there any specific documents needed to sustain the 510k exemption?
b) From the FDA sides, once I am sure that General Controls and applicable Special Controls have been addresses, I can start to sell the device in US without any notification to the agency?